Other royalties are primarily in respect of REMINYL and REMINYL XL (known as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.V. ("Janssen"), an affiliate of Johnson & Johnson. Shire has the exclusive marketing rights in the UK and the Republic of Ireland.
Barr and other companies have filed ANDA with the FDA for generic versions of RAZADYNE. Janssen and Synaptech Inc. ("Synaptech") have filed lawsuits against some of those ANDA filers. A trial was held during the week of May 21, 2007. No decision from the court has been issued to date.
Janssen and Synaptech filed lawsuits against Barr and Sandoz Inc. ("Sandoz") for infringement of their patent rights relating to RAZADYNE ER as a result of Barr and Sandoz filing ANDAs with the FDA for generic versions of RAZADYNE ER. No court dates have been set.
4. Financial details Cost of product sales
For the year to December 31, 2007 the cost of product sales was 14% of
product sales (2006: 16%). The cost of product sales for REPLAGAL in 2006
included a $47.0 million (3% of product sales) adjustment in respect of
inventories acquired through the acquisition of TKT. Excluding the impact
of this fair value adjustment, cost of product sales as a percentage of
product sales in 2006 was 13%. The increase in cost of product sales as a
percentage of products sales in 2007 over 2006 was primarily due to a shift
in product mix resulting from increased sales of launched products, which
had lower margins than existing products, and the write-off of inventory
following the voluntary market withdrawal of a limited quantity of DAYTRANA
For the year to December 31, 2007 cost of product sales included a charge
of $5.5 million for share based compensation (2006: $3.2 million) which
included a $2.1 million cumulative catch up charge in respect of t
|SOURCE Shire plc|
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